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Environmental fate & pathways

Biodegradation in water: screening tests

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Reference
Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
In Section 13 of the IUCLID dossier, a report is attached in which the category approach is reported according to ECHA Guidance for the implementation of REACH, Guidance on information requirements and chemical safety assessment, Chapter R.6 (reporting format for a chemical category).
Reason / purpose:
read-across source
Duration of test (contact time):
d
Parameter followed for biodegradation estimation:
CO2 evolution
Parameter:
% degradation (CO2 evolution)
Value:
18.3
Sampling time:
3 d
Remarks on result:
other: Mean of 2 replicates
Parameter:
% degradation (CO2 evolution)
Value:
46.9
Sampling time:
7 d
Remarks on result:
other: Mean of 2 replicates
Key result
Parameter:
% degradation (CO2 evolution)
Value:
59.2
Sampling time:
10 d
Remarks on result:
other: Mean of 2 replicates
Key result
Parameter:
% degradation (CO2 evolution)
Value:
79.8
Sampling time:
14 d
Remarks on result:
other: Mean of 2 replicates
Parameter:
% degradation (CO2 evolution)
Value:
103.3
Sampling time:
28 d
Remarks on result:
other: Mean of 2 replicates
Details on results:
- See the section "Any other information on results incl. tables"
- In both replicates the degree of biodegradation reached >10% (the start of the 10-d window) at day 3
- In 1 replicate the pass level for ready biodegradability (>60%) was reached at day 10 (61.4%). In the other replicate it was just below 60% (56.9%).
- The next sampling time after this was day 14, which is 11 days after the start of the 10-d window. The degree of biodegradation in this other replicate was 77.8% at day 14.
Results with reference substance:
The reference substance reached 82% biodegradation after 14 days in 1 replicate (results other 2 replicates not reported)

Inoculum blank (mean of 2 replicates)

Replicate 1

Replicate 2

 

Replicate 3 (not used for evaluation)

Day

Total CO2 release (mg IC/L)

Total CO2 release (mg IC/L)

Degradation (%)

Total CO2 release (mg IC/L)

Degradation (%)

Mean degradation (%)

Total CO2 release (mg IC/L)

Degradation (%)

0

0.0

0.0

0.0

0.0

0.0

0.0

0

0,0

1

-0.2

0.2

1.8

0.2

1.7

1.8

-0,1

0,5

3

-0.1

3.3

16.9

3.8

19.7

18.3

2,5

13,0

7

0.6

10.0

47.2

9.9

46.7

46.9

8,6

40,0

10

1.1

13.4

61.4

12.5

56.9

59.2

12,4

56,5

14

1.5

17.8

81.9

17.0

77.8

79.8

17,3

79,0

17

1.4

19.1

88.8

18.5

85.4

87.1

19,4

90,0

21

1.3

20.7

97.1

19.8

92.4

94.8

21,5

101,0

24

1.3

21.5

101.3

20.5

96.1

98.7

22,8

107,5

28

1.2

22.3

105.6

21.5

100.9

103.3

24,1

114,5

Validity criteria fulfilled:
yes
Remarks:
; <20% difference between the replicates at the end of the test; the percentage degradation of the reference substance reached the pass level by day 14; the CO2 evolution in the inoculum blank at the end of the test did not exceed 40 mg/L (=10.9 mg IC/L)
Interpretation of results:
readily biodegradable
Conclusions:
In a study with a related member of the chemical category (amphoacetates C12), conducted according to OECD 301B and GLP (no deviations), a degree of biodegradation of >60% was reached after 14 days. The validity criteria were fulfilled. The study only lacks the addition of a toxicity control. Based on the results of this study and the nature of the source chemical, amphoacetates C12 is considered to be readily biodegradable in accordance with the OECD Guideline. This result is read-across to the registered substance, member of the same chemical category.

Description of key information

Based on the results obtained in a study with a related member of the chemical category (amphoacetates C12), conducted according to OECD 301B and GLP, the substance is considered to be readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

Screening for ready biodegradability

In a study with a related member of the chemical category (amphoacetates C12), conducted according to OECD 301B and GLP (reliability 1), a degree of biodegradation of >60% was reached after 14 days. The validity criteria were fulfilled. Based on the results of this study and the nature of the source chemical, amphoacetates C12 is considered to be readily biodegradable in accordance with the OECD Guideline. This result is read-across to this substance, member of the same chemical category.

Screening for inherent biodegradability

From a study conducted similar to OECD 302B (reliability 4) it was shown that the substance is inherently biodegradable under the conditions of the OECD Guideline. The validity of this study cannot be assessed as no blank inoculum control was included and as the report lacks important details.